Cancer Research for the Ozarks

A Community Clinical Oncology Program Springfield, Missouri

Year in Review

2006-2007

The Year in Review

2011-2012

Cancer Research for the Ozarks The Year In Review 2011-2012

As I see it

This past grant year has been one of success for Cancer Research for the Ozarks (CRO). We have added nine new physician investigators to the roster, several of whom are surgeons. This is another demonstration of the acceptance of CRO by the medical staff of Mercy, CoxHealth and our affiliates. This past year we registered 93% of our NCI treatment credit accrual goal. Even more exciting is the fact that we exceeded our Cancer Control accrual goal by 16 credits. Overall we have registered 104% of the goals established by the National Cancer Institute. This is a stellar accomplishment and reflects the dedication of our investigators and loyal staff. I am especially pleased to acknowledge the accomplishments of our top investigators, Dr. Jay Carlson of Mercy and Dr. Al Bonebrake of CoxHealth. Our education program continues with offerings of national speakers on current oncology topics on a regular basis. In addition, in order to facilitate new working information for the group, we have instituted a monthly teleconference with our investigators, not only here in Springfield, but also at our satellites. This hour-long conference allows us to interact by video assisted computer link to update investigators on new protocols, obtain their approval for these protocols and also review potential new research studies. This monthly teleconference provides another structured educational experience. In light of last year‟s excellent past performance, we have been informed by National Cancer Institute that our next year of the current grant cycle has the potential of increased funding. This is truly exciting. In closing, I feel that CRO has the potential of being one of the best Community Clinical Oncology Programs in the nation. We are in a very strong position as we move ahead with our new grant application which we will be creating and fine tuning in preparation for the submission date of July 2013. I want to thank all members of the CRO team for their dedication and commitment to our patients and their belief that state of the art cancer treatment can only evolve through clinical trials.

Robert Carolla MD Principal Investigator

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Progress Report

Marilyn Bauer, BSN, MEd, MHA, CRO Director

CRO Outreach Results in New Research Affiliate

Phelps County Regional Medical Center (PCRMC) in Rolla, Missouri affiliated with Cancer Research for the Ozarks, (CRO), to enroll patients to clinical trials on May 25, 2011. This is an exciting event for CRO and oncology patients being cared for in the Rolla community.

In a unique agreement, PCRMC is working with the oncologists at Mercy Clinic Rolla for CRO research purposes. PCRMC has three medical oncologists, Dr. Joseph Bond, Dr. Ruth Nevils and Dr. Christiane Zoghbi, and a radiation oncologist, Dr. Mary Graham. Mercy Clinic Rolla is served by two medical oncologists, Dr. Syed Huq and Dr. Ali Yaqoob. All physicians are CRO investigators. Kristi Atkins is a full-time research nurse for both PCRMC and Mercy Clinic Rolla. Kristi was previously a chemo nurse in Drs. Ali & Huq‟s office. Kristi spent time in Springfield training with CRO staff on August 8-10, 2011 and January 30-31, 2012. CoxHealth‟s IRB is serving as the IRB of record for PCMRC. Because Mercy Clinic Rolla is a part of the Mercy System, Mercy Springfield is their IRB.

Mercy and Freeman CRO Affiliates in Joplin Our hearts were all saddened by the devastating effects the EF5 tornado brought to our affiliates at St. John‟s and Freeman in Joplin on May 22, 2011. St. John‟s Regional Medical Center was destroyed in the storm. We are all grateful that our Joplin investigators and nurses were safe. Our hearts and prayers were with Lois Crockett, research nurse at Freeman, who lost her home, car and all her belongings. CRO was in contact with the National Cancer Institute, (NCI) and kept them updated on the progress in securing our records. Unfortunately, research records have yet to be recovered. In the meantime our research nurse, Rita Glaze with Mercy Joplin, is working as best she can to enroll patients, and recently put her first patient on study since the storm. A new hospital is currently under construction.

NCI Supplements Tornado Victims CRO was granted a $5,137 supplement to assist our research nurse, Rita Glaze at Mercy Joplin to restore her office following the tornado. Rita‟s new laptop computer put her back in operation in a temporary trailer office shared with others. Other office equipment and supplies will be purchased when Rita has a more permanent location. We are grateful for this supplement and appreciate all of the emails of concern received from the NCI and cooperative groups regarding the May 22 Joplin tornado. They were most supportive.

CRO Research Drugs Moved to the CRO Administrative Office CRO research drugs were moved from a local pharmacy to the CRO Administrative Office on May 31, 2011. CRO Administrative Office staff now receives and handle drugs needed for clinical trials. CRO Administrative Office staff were trained in Pharmaceutical Management Branch guidelines. Mercy Springfield‟s pharmacy auditor, Morgan Thompson, reviewed CRO‟s policies and procedures regarding research drugs in January 2012. Her recommended changes to our bi-monthly drug auditing practice and our standard operating policy have been put in place. This move has allowed us to keep accurate records, has proven to be more

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convenient for CRO clinical staff and is a cost savings for our department. NCCTG and RTOG auditors found no errors with our handling and storage of drugs when they audited on February 2, 2012 and May 16, 2012 respectively.

CRO Steering Dinner Committee meetings On October 3, 2011 our second CRO Steering Committee meeting of the year was held. Dr. Carolla opened the meeting with CRO updates and statistical information. Dr. Mark Skelley from Joplin shared his interesting experience in surviving the Joplin tornado which destroyed St. John‟s Hospital and the office for his practice. Dr. Ravi Vij from Washington University School of Medicine in St. Louis spoke on multiple myeloma. Dr. Vij‟s professional focus is on hematological malignancies and the development of new treatments. He has initiated or been the principal investigator for 17 clinical trials, has presented at over 50 academic medical centers and professional societies, and authored over 70 manuscripts and books. Thirty-seven physicians, advanced practice nurses, research nurses and staff attended this event sponsored by Celgene Pharmaceutical Company. On May 10, 2012 Alain Mita MD, Co-Director, Experimental Therapeutics Program at Cedar-Sinai Medical Center spoke on “The Molecular Basis of Lung Cancer: Expand your Understanding on Lung Cancer Biology”. Educational objectives for this program included:

Refresh key concepts in cell-signaling pathways related to cancer biology

Update knowledge on targeted therapeutic approaches and their mechanisms of action in an unbranded environment

Share experiences and network with fellow oncologists through scientific discussions in a collegial atmosphere

This event was held at TOUCH restaurant and sponsored by Genentech. Twenty physicians, nurse practitioners and research staff attended the meeting.

CRO Web based monthly Educational Conference On Monday, May 7th at 12 noon the first monthly WebEx conference to discuss new studies and other events happening in research at CRO occurred. On Tuesday, May 8th at 5pm the conference call was repeated for those unable to attend the first meeting. CRO investigators, nurse practitioners and research staff were sent an email inviting them to the conference. The invite included a link to pull the conference up on their screen and a number to dial in. The meeting was automatically posted on the recipient‟s calendar. During the call, Dr. Carolla presented new studies available to our Community Clinical Oncology Program (CCOP). The call also included an administrative and educational update. Discussion and input from participants was sought. Going forward, CRO will be hosting two calls per month to meet the preferences of the medical oncologists at CoxHealth and Mercy. Calls are scheduled monthly on the Monday before the second Tuesday of the month at 12noon and the second Tuesday of the month at 5pm. CRO staff will set up the conference rooms at Cancer Hematology Center and Oncology Hematology Associates for our investigators and interested staff to join in as a group. The WebEx tool is highly interactive with logon capabilities from home computers, iPhones, iPads, Blackberries and so on as well as video capabilities with a web-cam. CRO views this as an opportunity to improve communications with our investigators and research staff. Our

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affiliate investigators and research staff are being included in the calls. CME‟s will are given for attendance.

Dr. Carlson NCI’s Top Enroller

Dr. Jay Carlson was recognized as the highest accruing investigator for treatment and treatment plus cancer control combined from his work at the Iowa CCOP during NCI grant year 2010-2011. This recognition was announced at the CCOP PI and Administrators meeting on September 27, 2011. We congratulate Dr. Carlson for this tremendous honor and look forward to his continued success with CRO.

Dr. Carolla SWOG Auditor Dr. Carolla served as a SWOG auditor in July 2011. He traveled to Kansas City to audit the Kansas City CCOP. Dr. Carolla enjoys serving as an auditor and frequently returns with ideas that will assist in improving our own CCOP.

CRO Staff Participate in Pink Glove Event CRO staff enjoyed a little fun wearing pink gloves, pink boas and dancing to “Firework” by Katy Perry by participating in Hulston Cancer Center‟s pink glove video. The video was produced to raise breast cancer awareness and offered an opportunity to win a donation to a local breast cancer charity.

CRO Communications CRO publishes a monthly CRO Communiqué. The Communiqué is sent electronically and mailed to each of our investigators, administrators and others interested in our program. In this publication we share monthly accrual statistics, recognize the leading physicians with trial enrollments, profile newly opened studies, announce upcoming CRO events, and share CCOP news. A list of recently opened and closed studies within the last month is also included. The CRO Director sends out a weekly update entitled, “Marilyn‟s Messages” to all CRO and affiliate staff. Her message is an effort to keep staff updated on recent happenings and to inform and unite staff housed at different sites. In addition to pertinent departmental news, the message includes accrual statistics.

CRO Accruals This has been an interesting year for accruals. Fifty-seven percent of our enrollments have been to GOG trials. We are fortunate to have two very involved gynecological oncologists. Together they have placed 143 of our 252 total patients on study, earning 86.2 of our 183.3 total credits. In February seventeen investigators enrolled 25 patients to 19 different trials. We earned 20.2 treatment and 8.6 control credits. February‟s enrollment is an indication of how hard our staff and investigators are working to serve the patients in our area. Our affiliates enrolled 22 patients this grant year earning 16.1 credits. As our two affiliates in Joplin recover from the devastation of the May 22, 2011 tornado we believe they will return as strong enrollers like they have been in past years. Our new Rolla affiliate has the possibility of becoming a strong clinical trial enroller. The research nurse in Rolla is full time, and has great

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interest and enthusiasm for research. They have placed nine patients on study since joining us on May 25, 2011.

CRO Staff

Our CRO staff includes the director, office manager, regulatory compliance coordinator, clinical research coordinator, 4.5 registered nurses and 3 clinical research assistants. The recent addition of our PRN research nurse, Sharon Brown, allows us more flexibility with staffing and increased time to devote to internal auditing and staff education. Sharon Brown joined CRO in September, 2011. She previously worked as a NCI research nurse at Freeman in Joplin. Amber Pierce, RN joined us as a full-time research nurse on October 17th filling a position vacated by retirement. Amber has worked in oncology for 10 years, most recently as the Assistant Nurse Manager on 500 West, the oncology unit at CoxHealth. The 4.5 research nurses and 3 clinical research assistants at CRO placed 252 patients on trial this past grant year. This is approximately 36 patients per staff. Our research nurses enroll to treatment trials and clinical research assistants enroll to control trials under the guidance of the research nurses and clinical research coordinator. Our clinical research coordinator and PRN research nurse assist our clinical staff as needed, staffing for vacations, performing internal auditing and providing staff education on clinical trial documentation. Using our CREDIT database, our staff record patient screenings if they spend more than 15 minutes to assess a patient„s trial eligibility. Although many additional hours are spent screening patients who require less than 15 minutes, the database shows 622 patients were screened over the past year. Screening time for these 622 patients resulted in approximately 720 hours of staff‟s time.

CRO Staff Transition On Wednesday, October 5, 2011, CRO Executive Board Administrators met to assess CRO staffing. It was decided to take the opportunity of new staff additions to make changes to better align staff with their strengths. Research nurse, Sharon Hodge transferred from CoxHealth to Mercy on October 19th to assist in covering Dr. Carlson‟s GYN oncology office. Amber Pierce RN joined our CRO Hulston staff at CoxHealth. Amber is familiar with the Hulston physicians and staff, and this had a positive influence her orientation and our success at this site. Sharon Brown, our new PRN nurse, assists at Cox and St. John‟s as well as performing internal chart auditing. We are very pleased to have both Amber and Sharon on board in their new positions.

Quality Assurance

Timely and accurate data submission is a very important ongoing goal at CRO. With the addition of a PRN research nurse to our staff this past year we are now able to devote the majority of our clinical research coordinator‟s time to internal auditing and staff education. It is CRO policy to internally audit one chart completely and three charts for eligibility quarterly for each staff placing patients on trial. Our clinical research coordinator is responsible for this

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auditing. He has worked with our new affiliate nurses at Skaggs, PCRMC and Central Care PA to audit and educate them on chart documentation for the past several months. Our plan is to audit these three new affiliates‟ documentation quarterly until they are secure with the process. Our regulatory files are audited monthly by our office manager, who was previously our regulatory compliance coordinator. She randomly selects three regulatory protocols each month for auditing.

Cooperative Group Transition

Our CCOP completed and submitted a Main Member application to Alliance, the merged group of NCCTG, CALGB and ACOSOG, on February 10, 2012. We were accepted as a member on May 4th. Our CCOP has had many enrollments to NCCTG and CALGB trials in the past. We look forward to giving our investigators access to these two groups‟ combined efforts through Alliance as well as providing more trials for our new surgical investigators.

Achieving Target Credit Goals

Yearly, the NCI sets credit goals for CCOPs. Credits are assigned to protocols and awarded to the CCOP when a patient is enrolled in a cancer treatment or prevention trial. Credits are also awarded for long-term follow up visits for patients in large cancer prevention trials. Cancer Research for the Ozarks‟ assigned NCI target credits for this fiscal year were 120 cancer treatment credits and 60 cancer control or prevention credits. At fiscal year‟s end, Cancer Research for the Ozarks had accumulated 111.4 cancer treatment credits and 76.1 cancer control credits. Credits are different from enrollments. An enrollment is defined as one patient enrolled into one trial. Enrollments tell us the number of patients in particular trials. Not all enrollments receive credit. Credits are the NCI value assigned to each trial registration. This past year, CRO had 256 enrollments for credit, and 2 no-credit enrollments, for a total of 258. Of that total, our affiliates in Joplin at St. John‟s Regional Medical Center, Freeman Health, Skaggs, and Central Cares PA contributed 24 enrollments. Our affiliates contributed 9% of our total enrollments this grant year. Last grant year our affiliates contributed 11% of our total enrollments.

CRO Finances

In 2008, Cancer Research for the Ozarks received a 5-year grant from the National Cancer Institute for $ 4,239,818 which supplied us with $566,009 this past fiscal year. Grant dollars go a long way, but do not completely support CRO. CRO is supported by the generosity of our two sponsoring health system, CoxHealth and Mercy Springfield. Since the beginning of CRO in 1985, these institutions have generously supported cancer research in our community by equally absorbing dollars not provided by our grant each year. CRO works hard to control expenses and has came a long way from fiscal year 2005-2006 when our expenses over grant revenue was $245,154. The two tables below compare our FY 2010-2011 and FY 2011-2012 revenues. Accounting, lab, radiology services and office space for staff are just a few of the many benefits our sponsors provide for CRO which are not reflected in the numbers below.

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Revenues Fiscal Year 2010-2011 Revenues Fiscal Year 2011-

2012

Federal 581,389 Federal $566.009

Other 397,049 Other $286,347

Total Revenues 978,438 Total Revenues $852,356

Total Expenses 964,056 Total Expenses $885,087

Remainder * +14,382 Deficit * -$32,732

*The deficit is split equally between CoxHealth and Mercy Springfield Fiscal year 2011-2012 –Deficit $16,366 to each institution Fiscal year 2010-2011 – Remainder was +$14,382

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Meeting the CRO Goals for 2011-2012

Last year, we defined goals. Below are the goals, and our report of progress toward meeting them.

CRO Goals Achievements

Goal 1. Increase accruals to NCI clinical trials

1. Exceed our target treatment credits for this grant year by 3%.

2. Meet our cancer control credits for grant year.

1. CRO earned 111.4 treatment credits and 76.1 cancer control credits this grant year.

2. We exceeded our NCI assigned control credits target goal of 60 by 21%. We fell short of our NCI assigned treatment goal of 120 by 8.6 credits or 7%.

Goal 2. Improve communication efforts to keep CRO investigators and health care extenders aware of clinical trial availability

1. Publish trials opened and closed each month in the CRO Communiqué.

2. Profile a new study each month in the CRO Communiqué.

3. Network with physicians keeping them updated on new trials available.

4. Update pocket list of studies available bi-monthly and deliver to investigators.

5. Hold twice yearly CRO Steering Committee meetings with national speakers on new cancer therapies and treatments.

6. Distribute pocket cards of open studies at tumor conferences at Cox and St. John‟s.

1., 2. & 3. Monthly the CRO Communiqué is published and includes a list of open and closed trials, profiles a new study opening or one needing to be reemphasized. The Communiqué is distributed by email and in hard form to CRO investigators. 4. Every other month our pocket card listing of available studies is updated and distributed to investigators, nurse practitioners and other research staff. 5. Our CRO Steering meetings were held on October 3, 2011 and May 10, 2012 as previously shared in this report. 6. Pocket cards have not been distributed at tumor conferences as CRO investigators receive them via staff delivery to their office. Others attending tumor conference such as pathologist and radiologist are not CRO investigators.

Goal 3. Increase new investigators and affiliate participation in clinical trials

1. Contact surgeons to explore their participation in clinical trials by July 1, 2011.

2. Explore the possibility of an affiliation with Phelps County Hospital in Rolla, Missouri. September 1, 2011 is a target date for an affiliation completion.

3. Revise affiliate contract to require a minimum number of enrollments to remain involved with CRO.

1. CRO has added three new surgeons to our list of investigators this past year and continue to work with other surgeons exploring their interest in becoming CRO investigators. The new surgeons we have added to our investigator list have placed 15 patients earning 15 cancer control credits to our total this year.

2. Phelps County joined CRO on as an affiliate on May 25, 2011. Phelps County investigators have placed 9 patients on study since joining us.

3. Our affiliate contracts have been revised to include the requirement for a minimum of 5 patients be placed on study

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4. Require a minimum number of

affiliate enrollments before RN staff is sent to research base meetings.

5. Work with affiliates to encourage their enrollments to clinical trials.

yearly to remain in good standing with CRO. 4. The contract also includes the requirement that at least 10

patients be placed on study yearly before consideration is given to send research staff to national conferences.

5. We are working very closely with our three new affiliates. We are reviewing patient eligibility prior to patients being placed on study and internally auditing documentation of each affiliate patient enrolled from our new sites.

Goal 4. Ensure quality at CRO 1. Complete transfer of research

drugs to the CRO Administrative Office by June 1, 2011.

2. Re-evaluate the staffing structure at CRO by August 1, 2011.

3. Work for improved quality assurance at CRO with: - Timely and accurate data submission - Decrease queries and turnaround time to address those that do occur - Quarterly departmental chart audits - Train CRAs to develop data submission skills to assist RNs

1. CRO research drugs were moved to our administrative office on June 1, 2011. This move has allowed us to keep accurate records, has proven to be more convenient for CRO clinical staff and is a cost savings for our department.

2. On Wednesday, October 5, 2011, CRO Executive Board Administrators met to assess CRO staffing. It was decided to take the opportunity of new staff additions to make changes to better align staff with their strengths. Changes to staff assignments were made and a new part-time research nurse position was approved. This has allowed us to devote a full time position to internal auditing and staff education.

3. Quality assurance is an ongoing responsibility at CRO. The addition of a part time research nurse has allowed CRO to assign our full time study coordinator to internal auditing and staff education. Through chart auditing much education is occurring. Our CRA‟s do a wonderful job with enrolling patients to cancer control trials giving the research nurses more time to focus on treatment studies.

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Cancer Research for the Ozarks grant year 2011-2012

Goals & Opportunities for CRO in Grant Year 2012-2013 are as follows: Goal 1. Increase accruals to NCI clinical trials

Meet our target treatment credits for the grant year.

Exceed our cancer control credits for this grant year by 3%.

Continue to work with surgeons at both Cox and Mercy Springfield to explore their interest in participating in clinical trials by July 1, 2012.

Continue to publish trials opened and closed each month in the CRO Communiqué.

Continue to profile a new study each month in the CRO Communiqué.

Update pocket list of studies available bi-monthly and deliver to investigators.

Explore development of a monthly web-based conference call meeting to discuss new studies and other CRO business by June 1, 2012. All CRO investigators and research staff including CRO affiliates would be highly encouraged to attend.

Goal 2. Improve communication efforts to keep CRO investigators and staff aware of clinical trial availability

Visit yearly with physicians and staff at each of our affiliates to offer assistance and encourage enrollment to trials

Hold twice yearly CRO Steering Committee meetings with national speakers on new cancer therapies and treatments.

Explore development of a monthly web-based conference call meeting to discuss new studies and other CRO business by June 1, 2012. All CRO investigators and research staff including CRO affiliates would be highly encouraged to attend.

Goal 3. Ensure quality at CRO

Audit all new research staffs‟ (including affiliates) documentation for the first three months of employment.

Randomly select five patient records from each staff enrolling patients for quarterly eligibility auditing.

Quarterly conduct a complete audit on a minimum of one chart per enrolling staff

Work for improved quality assurance at CRO with: 1. Maintaining timely and accurate data submission. 2. Decreasing queries and turnaround time to address those that do occur. 3. Training CRAs to develop data submission skills to assist RNs

Goal 4. Promote CRO on a National Level

PI and director to volunteer in NCI committees

Check into being an NCI grant reviewer

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Protocol Reports: 2-Year Comparison of Registrations & Credits

Treatment

RESEARCH

BASE

2010-2011

REGISTRATIONS

2010-2011

CREDITS

2011-2012

REGISTRATION

S

2011-2012

CREDITS

CTSU 52 44.4 33 23.2

GOG 26 19.7 103 59.3

MD Anderson 0 0 0 0

NCCTG 4 4.0 0 0

NSABP 2 3.0 5 5.4

RTOG 5 6.0 3 3.5

SWOG 27 27.0 18 20

Suncoast 0 0 0 0

Wake Forest 0 0 0 0

Grand

Totals

116 104.1 162 111.4

Cancer Control & Prevention

RESEARCH

BASE

2010-2011

REGISTRATIONS

2010-2011

CREDITS

2011-2012

REGISTRATIONS

2011-2012

CREDITS

CTSU 20 17.0 8 6

GOG 18 13.0 39 24.9

MD

ANDERSON

0 0

0

0

NCCTG 1 1.0 11 11

NSABP

(new)

1 1.0 23 19.6

NSABP

(follow up

visits)

29 9.6 15 4.1

RTOG 10 9.0 2 1

Suncoast 0 2 2

SWOG (new) 8 7.0 3 1.5

SWOG

(follow up

visits)

25 6.3 0 0

WAKE

FOREST

0 0 6 6

Grand

Totals

112 Includes f/u visits

63.9 109 76.1

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Registrations by Affiliate/Site (Follow up credits not included)

AFFILIATE*/SITE 2010-2011

REGISTRATIONS

2010-2011

CREDITS

2011-2012

REGISTRATIONS

20110-2012

CREDITS

Central Care, PA

3 3.0 0 0

Cancer Hematology Center

48 40.1 44 38.9

Cox Surgeons 15 15.0

Ferrell-Duncan Clinic Gynecological

28 26.0 51 50.4

Freeman Medical Center (Joplin)

7 5.3 8 5.3

St. John‟s Regional Med Center (Joplin)

4 4.0 2 1.5

Phelps County Regional Medical Ctr.

9 6.5

Oncology Hematology Associates

47 46.0 24 21.2

Radiation Therapy Center

4 4.0 0 0

Skaggs Regional Medical Center

0 0 5 2.8

Mercy Women‟s Oncology Care

30 20.7 92 35.8

Mercy Springfield‟s Radiation Oncology.

3 3.0 6 6.0

No Credit at Mercy 2 0

Grand Totals 174 152.1 258 183.4

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All-inclusive 12-month Accrual for All Types of Protocols by Research Base

RESEARCH

BASE

2010-2011

REGISTRATIONS

2010-2011

CREDITS

2011-2012

REGISTRATIONS

2011-2012

CREDITS

CTSU 71+1 61.4 41 29.2

GOG 44 32.70 142 84.2

MD ANDERSON 0 0 0 0

NCCTG 5+1 5.0 11 11.0

NSABP 3 4.0 28 25.0

RTOG 15 15.0 5 4.5

SWOG 35 34.00 21 21.5

Suncoast 0 0 2 2

WAKE FOREST 0 0 6 6

Total Reg.

& Credits

173+2 152.1 256 183.4

Industrial

Trial Reg.

5 0 2 0

Plus

follow-up

--- 15.9 --- 4.1

Grand Total 180 168.0 258 187.5

*Credit + noncredit registrations. **Registrations totaled.

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Patient Registrations by Physician through May 31, 2012

1st Quarter 2nd Quarter 3rd Quarter 4th Quarter

Total Credits Earned for

Registrations c n/c c n/c c n/c c n/c c n/c

Abdalla 0 0 0 0 0 0 0 0 0 0

Albritton 0 0 0 0 0 0 0 0 0 0

Ali, Yaqoob 1 0 2 0 1 0 4 0 3.2

Amir 0 0 0 0 0 0 0 0 0 0

Biggers 0 0 0 0 1 0 7 0 8 0 8.0

Bond 0 0 0 0 0 0 4 0 4 0 2.3

Bonebrake 18 0 12 0 12 0 9 0 51 0 50.4

Braun 0 0 0 1 1 0 0 0 1 1 1.0

Buckner 7 0 0 0 7 0 7.0

Carlson 46 0 28 0 14 0 4 0 92 0 35.8

Clouse 0 0 0 0 0 0 0 0 0 0

Croy 0 0 0 0 0 0 0 0 0 0

Cunningham 0 0 0 0 2 0 3 0 5 0 5.0

Ding 0 0 0 0 2 0 0 0 2 0 2.0

Ellis 3 0 1 0 1 0 6 0 11 0 8.3

Farber 0 0 0 0 0 0 0 0 0 0

Gillett 0 0 1 0 1 0 0 0 2 0 2.5

Goodwin 3 0 0 0 2 0 0 0 5 0 2.8

Hassan 0 0 0 0 0 0 0 0 0 0

Holden 1 1 2 0 2 0 2 0 7 1 7.0

Hoos 1 0 0 0 1 0 2 0 4 0 4.0

Kent, Elizabeth 2 0 0 0 1 0 0 0 3 0 2.5

Kim, Helen 0 0 0 0 5 0 0 0 5 0 5.0

LaFrancis 0 0 0 0 0 0 0 0 0 0

Myers 0 0 0 0 0 0 0 0 0 0

Miller 0 0 0 0 2 0 0 0 2 0 1.5

Nair 0 0 5 0 0 0 0 0 5 0 4.5

Nanney 3 0 0 0 0 0 0 0 3 0 2.2

Nevils 0 0 0 0 0 0 1 0 1 0 1.0

Raju 0 0 1 0 0 0 2 0 3 0 3.0

Ross 0 0 0 0 0 0 0 0 0 0

Sciortino 3 0 3 0 1.3

Shunyakov 0 0 0 0 0 0 0 0 0 0

Skelley 0 0 0 0 2 0 0 0 2 0 1.5

Tiriveedhi 0 0 13 0 2 0 4 0 19 0 15.7

Tummala 2 0 1 0 3 0 2.5

Driver 0 0 0 0 0 0 0 0 0 0 Williams 3 0 0 0 1 0 0 0 4 0 3.4 Woodall 0 0 0 0 0 0 0 0 0 0

Total 80 1 64 1 63 0 49 0 256 2 183.4

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Top 10 Protocols by Registration

Rank Protocol Title #

Registrations Credits

1 GOG-0136

Acquisition of Human Gynecologic Specimens and Serum to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of Cancer

46 4.6

2 NSABP DMP-1

A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer

15 15

3 GOG-0262

A Randomized Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination with Carboplatin with or without Concurrent and Consolidation Bevacizumab in the Treatment of Primary Stage III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer

10 15.0

4 GOG-0247

Patient, Physician and Nurse Factors Associated with Entry onto Clinical Trials and Completion of Treatment for Women with Primary or Recurrent Invasive Carcinoma of the Uterine Corpus or Uterine Cervix, All Stages

10 9.4

5 NCCTG N10C1

Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo-Controlled Trial

8 8.0

6 GOG-0235

A Prospective, Longitudinal Study of YKL-40 in Patients with FIGO Stage III or IV Invasive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Undergoing Primary Chemotherapy

8 2.4

7 GOG-0252

A Phase III Clinical Trial of Bevacizumab with IV versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

6 9.0

8 CALGB 80702

A Phase III trial of 6 versus 12 Treatments of Adjuvant Folfox plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer

6 7.2

9 Wake Forest 97609

Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity

6 6.0

10 GOG-0186G

A Phase II Randomized, Double Blinded Evaluation of Oral Everolimus (RAD001) Plus Bevacizumab vs. Oral Placebo Plus

6 6.0

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Bevacizumab in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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Cancer Research for the Ozarks Staff

Robert L. Carolla, MD, Principal Investigator

V. Roger Holden, MD, Associate Principal Investigator

Marilyn Bauer, BSN, MEd, MHA, Director

Sharon Brown, RN, Research Nurse

Debbie Cane, AA, Office Manager

Kathy Coleman, BSN, Research Nurse

Cynthia Dievert, Clinical Research Assistant

Lisa Hamilton, LPN, Clinical Research Assistant

Sharon Hodge, RN, Research Nurse

Amber Pierce, RN, Research Nurse

Basava Raju, MS, BS, CCRP, Research Coordinator

Rita Ritter, Clinical Research Assistant

Stephanie Sekscinski, Regulatory Compliance Coordinator

Marcia Thompson, BSN, Research Nurse

Cancer Research for the Ozarks

has a mission rooted in the spirit of collaboration between CoxHealth and Mercy Springfield.

Inspired by our faith-based call to serve others, we seek to promote the

quality of life within the communities we serve by providing innovative cancer research, education, and personal compassionate presence to our

patients, family members, and staff.